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Superior reductions in spleen volume and improvements in Total Symptom Score (TSS) vs placebo.1,2
Learn more at www.jakafi.com.
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Learn more >
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Jakafi™—the first and only FDA-approved agent for intermediate or high-risk myelofibrosis1
Dear Dr [Name],
Consider Jakafi for your patients with intermediate or high-risk myelofibrosis. Jakafi reduces splenomegaly and improves the symptoms of myelofibrosis, as measured by TSS.* Symptoms measured by TSS were abdominal discomfort, early satiety, pain under left ribs, pruritus, night sweats and bone/muscle pain. In a clinical study, most patients receiving placebo experienced increased splenomegaly and worsening of symptoms.1,2
Myelofibrosis is a life-threatening and debilitating hematologic malignancy3-5
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Myelofibrosis is characterized by increased splenomegaly (in 85% or more of patients), worsening symptoms and cytopenias6,7
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Survival in myelofibrosis varies but can be as little as ~2 years in high-risk patients4
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The majority of patients with myelofibrosis experience debilitating symptoms8
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Order the Myelofibrosis Brochure >
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Jakafi demonstrated superior reduction in spleen volume and significant improvement in symptom scores1,2
41.9% vs 0.7%1,2†
Patients achieving a >35% reduction in spleen volume at 24 weeks vs placebo (COMFORT-I)
(P < 0.0001)
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28.5% vs 0%1,2‡
Patients achieving a >35% reduction in spleen volume at 48 weeks vs best available therapy (BAT) (COMFORT-II)
(P < 0.0001)
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45.9% vs 5.3%1,2†
Patients achieving a >50% improvement in TSS at 24 weeks vs placebo (COMFORT-I) (P < 0.0001)
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Reductions in spleen volume and improvements in TSS were seen with Jakafi in both JAK2V617F-positive and JAK2V617F-negative patients, relative to placebo.2
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Each bar represents an individual patient's response. |
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Each bar represents an individual patient's response. Worsening of TSS is truncated at 150%. |
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Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia
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Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections
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The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
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Please see Important Safety Information.
Learn more about how Jakafi can help your patients >
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*
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TSS was captured by the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0), a daily patient diary recorded for 25 weeks. Symptom scores ranged from 0 to 10 with 0 representing symptoms "absent" and 10 representing "worst imaginable" symptoms. These scores were added to create the daily total score, which has a maximum of 60. At baseline, mean TSS was 18.0 in the group receiving Jakafi and 16.5 in the placebo group.1,2
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†
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Based on COMFORT-I, a randomized, double-blind, placebo-controlled study in patients with myelofibrosis who were refractory to or not candidates for available therapy.1
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‡
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Based on COMFORT-II, an open-label, randomized study of Jakafi vs BAT.1
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IncyteCARES (Connecting to Access, Reimbursement, Education and Support)
IncyteCARES offers free educational support for your patients taking Jakafi.
Order the IncyteCARES Patient Starter Packet >
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Indications and Usage
Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis.
Important Safety Information
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Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required
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The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
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Patients with platelet counts <200 x 109/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered
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Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered
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Neutropenia (ANC <0.5 x 109/L) was generally reversible and was managed by temporarily withholding Jakafi
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Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly
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A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy
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There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus
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Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
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Please see Full Prescribing Information.
References: 1. Jakafi Prescribing Information. Incyte Corporation. November 2011. 2. Data on file. Incyte Corporation. 3. Lichtman MA, Tefferi A. Primary myelofibrosis. In: Kaushansky K, Lichtman MA, Beutler E, Kipps TJ, Seligsohn U, Prchal JT, eds. Williams Hematology. 8th ed. New York, NY: McGraw Hill Medical; 2010:1381-1399. 4. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113:2895-2901. 5. Mesa RA, Schwager S, Radia D, et al. The Myelofibrosis Symptom Assessment Form (MFSAF): an evidence-based brief inventory to measure quality of life and symptomatic response to treatment in myelofibrosis. Leuk Res. 2009;33:1199-1203. 6. Verstovsek S, Kantarjian H, Mesa RA, et al. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010;363:1117-1127. 7. Barosi G. Myelofibrosis with myeloid metaplasia: diagnostic definition and prognostic classification for clinical studies and treatment guidelines. J Clin Oncol. 1999;17:2954-2970. 8. Scherber R, Dueck AC, Johansson P, et al. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients. Blood. 2011;118:401-408.
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Jakafi is a trademark of Incyte Corporation.
© 2012, Incyte Corporation. All rights reserved. RUX-1127 04/12
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Incyte Corporation
P.O. Box 4689
Trenton, NJ 08650
Replies to the email address do-not-reply@incyte.com will not be processed.
For more information, please contact us at 1-855-4-Jakafi (855-452-5234).
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